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This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS) in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low light dose | Experimental | PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes |
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| high light dose | Experimental | PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoporfin PDT | Drug | Photodynamic therapy is performed using hemoporfin. Hemoporfin(5mg/kg)is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%) | week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lin Ma, MD | Bejing Children's Hospital, Capital Medical University | Principal Investigator |
| Jining Tao | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Beijing | 100045 | China |
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| ID | Term |
|---|---|
| D019339 | Port-Wine Stain |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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| D017437 | Skin and Connective Tissue Diseases |